ImmunoVEXHSV2, an investigational vaccine against genital herpes developed by BioVex Inc, is undergoing first-in-man clinical studies.
ImmunoVEXHSV2 is based on an engineered form of the causative agent of genital herpes, HSV-2, from which genes that collectively interfere with the functions of immune system have been deleted. The proteins encoded by these genes aid wild type HSV-2 in evading the body’s immune system.
ImmunoVEXHSV2 expresses all but four of the approximately 80 HSV-2 proteins, maximizing the breadth of the anti-HSV immune response generated, but without the genes encoding for these immune-inhibiting proteins.
ImmunoVEXHSV2 has been evaluated in the industry-standard preclinical model of genital herpes, in which it completely prevented disease, suggesting that ImmunoVEXHSV2 may be more potent in humans than other HSV-2 vaccines for which published data is available.
The vaccine also considerably reduced the level of viral shedding following exposure, which if this translates to the clinical setting, may also reduce any window of infectivity from an infected individual.
The first subject had been dosed in the Phase 1 study of its live attenuated genital herpes vaccine, ImmunoVEXHSV2, BioVex Inc announced.
The Phase 1, open label trial to assess safety and immune response to ImmunoVEXHSV2 in healthy volunteers, is taking place in the UK at the Chelsea and Westminster Hospital in London and will involve up to 42 already identified subjects.
“Developing an effective vaccine against genital herpes has historically proved challenging. ImmunoVEX is a rationally designed live attenuated vaccine specifically constructed to address the limitations of previous vaccines,” stated Dr. Robert Coffin, Founder & CTO for BioVex in a press release.
At least 45 million people over the age of 11 in the United States have been infected with HSV-2, the causative agent of genital herpes, the rate of infection having increased approximately 30% between the late 1970s and the early 1990s, according to the Centers for Disease Control and Prevention.
In addition to genital lesions, patients with compromised immune systems may experience more severe, systemic complications, including in some cases cystitis, urethritis, cervicitis and meningitis.
According to research reported in Biomed Central’s journal BMC Infectious Diseases, the economic burden of genital HSV infection and resulting complications has been estimated to be greater than $1 billion annually in the United States alone.
BioVex is a privately held biotechnology company based in Woburn, Mass. where it also has an operational launch grade manufacturing facility. The Company is developing a new class of biologics for the treatment of cancer and prevention of infectious disease.
The company’s lead product, OncoVEXGM-CSF is a first in class oncolytic vaccine. OncoVEXGM-CSF replicates selectively in tumors; destroying cancer cells whist leaving surrounding healthy cells unharmed. OncoVEXGM-CSF is also intended to induce a powerful immune response to kill cancer cells throughout the body.